What are the responsibilities and job description for the Validation Supervisor position at Renaissance Lakewood LLC?
This position is responsible for Equipment, critical utilities and facilities Validation activities (i.e. included but not limited to Manufacturing and packaging equipment, critical utilities including WFI, compressed gases, clean steam, etc.), that supports commercial and new R & D drug product development activities in support of the specific client projects involving all delivery systems manufactured at Renaissance Lakewood LLC, NJ plant. This highly technical and highly specialized position is responsible for generating, reviewing, and approving qualification protocols, deviations and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports. The individual will be a Subject Matter Expert (SME) expected to oversee the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).This position will also interact frequently with regulatory/compliance personnel at Renaissance. It will assure compliance to all FDA and international regulations with regard to validation activities. The employee in this role must be able to represent Renaissance with customers and senior management. Carry out team lead / team oversight responsibilities in accordance with the organization's policies. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
